Purpose of this Study
We are doing this study to compare two different treatment options for mantle cell lymphoma. We want to find out which option has the best outcomes for older adults. We will compare the results of continuous treatment with zanubritinib to treatment with zanubrutinib that is stopped after the initial six 28-day cycles of chemotherapy and restarted only if your disease gets worse following the initial six 28-day cycles of chemotherapy.
Who Can Participate?
Eligibility
Adults who:
- Are diagnosed with mantle cell lymphoma
- Are at least 70 years old OR at least 60 years old and not a candidate for an autologous stem cell transplant
- Have never received a stem cell transplant
- Have not received any previous systemic therapy for mantle cell lymphoma
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.
- Are diagnosed with mantle cell lymphoma
- Are at least 70 years old OR at least 60 years old and not a candidate for an autologous stem cell transplant
- Have never received a stem cell transplant
- Have not received any previous systemic therapy for mantle cell lymphoma
For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.
What is Involved?
If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:
- Group 1 will get rituximab (or rituximab biosimilar) through a vein in the arm or an injection under the skin on Day 1 of each cycle and take zanubrutinib by mouth on days 1-28 of each cycle for six 28-day cycles. After completing 6 cycles, you will continue to take zanubritinib by mouth on days 1-28 of each cycle until your disease gets worse.
- Group 2 will get rituximab (or rituximab biosimilar) through a vein in the arm or an injection under the skin on Day 1 of each cycle and take zanubrutinib by mouth on days 1-28 of each cycle for six 28-day cycles. After completing 6 cycles, you will go into observation (clinic visits every 3 months) until your disease gets worse. Then, you will take zanubritinib by mouth on days 1-28 of each cycle until your disease gets worse again. You will be asked to complete a medication diary for zanubrutinib.
- Group 1 will get rituximab (or rituximab biosimilar) through a vein in the arm or an injection under the skin on Day 1 of each cycle and take zanubrutinib by mouth on days 1-28 of each cycle for six 28-day cycles. After completing 6 cycles, you will continue to take zanubritinib by mouth on days 1-28 of each cycle until your disease gets worse.
- Group 2 will get rituximab (or rituximab biosimilar) through a vein in the arm or an injection under the skin on Day 1 of each cycle and take zanubrutinib by mouth on days 1-28 of each cycle for six 28-day cycles. After completing 6 cycles, you will go into observation (clinic visits every 3 months) until your disease gets worse. Then, you will take zanubritinib by mouth on days 1-28 of each cycle until your disease gets worse again. You will be asked to complete a medication diary for zanubrutinib.
Study Details
Full Title
A052101: A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy with Zanubrutinib as Upfront Treatment in Older Patients with Mantle Cell Lymphoma
Principal Investigator
Matthew
McKinney
Protocol Number
PRO00114717
NCT ID
NCT05976763
Phase
III
Enrollment Status
Open to Enrollment